ESRDNCT03480178
Renal Anemia Refractory to Erythropoietin
An observational study of ESRD and Renal Anemia, run by Assiut University.
Trial summary
This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ESRD, Renal Anemia
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: 1. The investigators choose 50 uraemic patients on hemodialysis randomly and receiving Epo.among those admitted to nephrology ward and out Patient clinic of the department of internal medicine of Assiut University Hospital. 2. Follow up of patients for 6 months with CBC every month. 3. Searching for number of patients among this 50 who have failure to correct the anemia with Epo. (100IU /Kg / week- SC ) For target HB 11 gm. 4. Effect of bleeding, infection and malnutrition. 5. Scaring for the possible underling cause of anemia refractory to Epo. Clinically, laboratory at the end of study period.
Who may be able to join
- Patients greater than or equal to 18 years old with CKD on hemodialysis
Who cannot join
- - Evidence of infections especial of vascular access .
- - malnutrition and manifestation of iron, B12, folate and protein deficiency .
- - any underling cause as;
- Hematologic malignances -Hemolytic anemia -
- Aplastic anemia (infection and/or bleeding with anemia)
- Solid tumors
Show all 9Show fewer
- Bleeding (skin ,mucosal ,orificial)
- Evidence of mineral bone disease (CKD-MBD)
- Others
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients.
Read the detailed description
Chronic kidney disease (CKD) is considered a public health problem worldwide with high incidence and prevalence rates.Anemia is one of the most frequent early complication of CKD. The main cause is erythropoietin (EPO) deficiency due to impaired kidney function However, other causes should be considered when the severity of anemia is inconsistent with the decrease in renal function; when there is evidence of iron deficiency or matching decreases in hemoglobin, leukopenia and/or thrombocytopenia are also found
- Conditions
- ESRD, Renal Anemia
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal anemia refractory to erythropoietin
1 .Measurement of Hemoglobin , feritin and reitculocyte of patient before treatmeant by Epo. 100IU per Kg per week-SC.
2- Assessment to measure of hemoglobin of patient after treatment
Measured: 1 months
Secondary outcomes (1)
Renal anemia refractory to erythropoietin
1 .Measurement of Hemoglobin of patient by CBC before treatmeant by Epo. 100IU per Kg per week-SC?
2- Assessment to hemoglobin of anemic patient during the specified post -dose period ,6months
Measured: 6MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startJan 2019 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zaher alwi hadi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480178
- Sponsor's protocol ID
- 17100366
- Status last verified
- Dec 2018
- First submitted
- 13 Feb 2018
- Last updated
- 2 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Anemia Refractory to Erythropoietin
- ClinicalTrials.gov ID
- NCT03480178
- Acronym / sponsor ID
- 17100366
- Conditions
- ESRD, Renal Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients.
Detailed description
Chronic kidney disease (CKD) is considered a public health problem worldwide with high incidence and prevalence rates.Anemia is one of the most frequent early complication of CKD. The main cause is erythropoietin (EPO) deficiency due to impaired kidney function However, other causes should be considered when the severity of anemia is inconsistent with the decrease in renal function; when there is evidence of iron deficiency or matching decreases in hemoglobin, leukopenia and/or thrombocytopenia are also found
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 1. The investigators choose 50 uraemic patients on hemodialysis randomly and receiving Epo.among those admitted to nephrology ward and out Patient clinic of the department of internal medicine of Assiut University Hospital. 2. Follow up of patients for 6 months with CBC every month. 3. Searching for number of patients among this 50 who have failure to correct the anemia with Epo. (100IU /Kg / week- SC ) For target HB 11 gm. 4. Effect of bleeding, infection and malnutrition. 5. Scaring for the possible underling cause of anemia refractory to Epo. Clinically, laboratory at the end of study period.
Key inclusion criteria (1 listed)
- Patients greater than or equal to 18 years old with CKD on hemodialysis
Key exclusion criteria (9 listed)
- - Evidence of infections especial of vascular access .
- - malnutrition and manifestation of iron, B12, folate and protein deficiency .
- - any underling cause as;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal anemia refractory to erythropoietin
Time frame: 1 months
1 .Measurement of Hemoglobin , feritin and reitculocyte of patient before treatmeant by Epo. 100IU per Kg per week-SC. 2- Assessment to measure of hemoglobin of patient after treatment
1 secondary outcome
Renal anemia refractory to erythropoietin
Time frame: 6MONTHS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD and Renal Anemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zaher alwi, master (01020361266, binalwi2009@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal anemia refractory to erythropoietin (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.